Lev Korolkov Email & Phone Number

Munich, By, De

Germany

Munich, Bavaria, Germany

Therapyte (DataMatrix GmbH) is a healthtech company creating products for healthcare professionals based on real-world data. Big amounts of anonymized patients data are collected from the hospitals, registries, insurance companies and scientific articles, processed with AI models and packed into the web applications for health industry.Achievements:• Successfully launched 3 web applications (budget over €1 mln.) for healthcare professionals what allowed to improve clinical decisions• Achieved 25% increase in Monthly Active Users by improving app usability in 6 months• Completed on schedule 4 data-science projects in 12 months for big Pharma Sponsors – Novartis, Johnson & Johnson and Abbott Laboratories• Collaborated with business development department in 3 industry conferences what increased amount of leads by 15%• Led a cross-functional 9-member team of software engineers, product designer, biostatisticians, data-scientists, QAs to deliver a successful product launch

• Management of study budget, out of scope negotiation• Building ang managing the project team• Project planning (preparation of project plans, study manuals and guidelines, etc)• Organization of CRA trainings, study team, kick-off and investigators' meetings• Reporting to and communication with the Sponsor• Selection and management of study vendors• Organization of regulatory submissions in the EU region, Georgia, Kazakhstan• Co-monitoring of study sites• Review of all types of CRA reports• Assistance to Business Development in bid defense meetings

• Organized and controlled feasibility studies• Performed all types of monitoring visits• Reviewed monitoring reports• Conducted study team meeting• Assisted in monthly project reports• Performed CRA supervision• Implemented enrollment rescue plan

• organized and controlled feasibility study• wrote monitoring plan for the study• reviewed monitoring reports• handled schedule of monitoring visits• assisted with regulatory submissions in Russia and Belarus• coordinated and attended teleconferences with the sponsor• acted as a back-up Project Manager in the study• performed selection, initiation and monitoring visits

• assured adherence to the protocol, GCP and regulatory requirements• performed feasibility study• prepared documents for investigational product release• performed qualification, initiation, monitoring, close-out and co-monitoring visits• performed source data verification• handled CRFs, queries and data-base lock• assisted organization of investigators’ meeting• maintained timely delivery of investigational product and materials to the sites• facilitated serious adverse events reporting• managed sites and investigators payments• participated in preparation for audit at investigator site• assisted in maintenance of site part of trial master file• supervised and trained junior level CRAs

Master Of Science, Management. Focus: Digital Products

TUM School of Management

Specialist Degree, Economics And Management, 4,7 Out Of 5

Activities and Societies: Member of student councilNYCOMED scholarship for students with outstanding academic record Work&Travel USA –.

Certified Pharmacist (Internatura), Economics And Management